Table 4.
Analysis of primary and secondary outcomes by using last observation carried forward method
| Outcomes | Group | Mean ± SDa | P-value for EA × CBZ × time 3-way interactiong | P-value for EA × CBZ interactiong | P-value for main effect of EAg | P-value for main effect of CBZg | P-value for main effect of timeg | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n = 120) | Week 2 (n = 120) | Week 4 (n = 120) | Week 16 (n = 120) | Week 28 (n = 120) | |||||||
| VAS scoreb | EA + CBZ | 6.3(1.1) | 4.0(1.3) | 1.7(1.2) | 1.4(1.6) | 1.8(1.8) | 0.014* | 0.034* | < 0.001* | < 0.001* | < 0.001* |
| SEA + CBZ | 6.5(1.2) | 4.5(1.8) | 3.5(1.7) | 2.7(2.1) | 2.8(2.4) | ||||||
| EA + P | 6.3(1.0) | 4.6(1.0) | 2.6(1.2) | 1.6(1.8) | 1.6(1.7) | ||||||
| SEA + P | 6.0(1.1) | 5.5(1.4) | 5.1(1.5) | 4.6(1.9) | 4.5(2.0) | ||||||
| SF-MPQc | |||||||||||
| PRI | EA + CBZ | 14.6 (4.8) | 6.0 (3.8) | 3.7 (3.7) | 3.6 (3.6) | 3.6 (4.6) | 0.044* | 0.019* | < 0.001* | 0.009* | < 0.001* |
| SEA + CBZ | 12.8 (5.2) | 8.1 (4.9) | 6.8 (4.1) | 5.4 (4.5) | 5.3 (4.5) | ||||||
| EA + P | 14.8 (6.2) | 7.9 (4.3) | 4.4 (3.3) | 2.9 (4.2) | 2.4 (2.9) | ||||||
| SEA + P | 13.2 (4.8) | 10.7 (4.2) | 10.5 (4.4) | 9.6 (5.9) | 9.2 (5.7) | ||||||
| PPI | EA + CBZ | 1.8 (1.3) | 1.0 (1.0) | 0.5 (0.7) | 0.5 (0.7) | 0.5 (0.8) | 0.046* | 0.171 | 0.001* | 0.038* | < 0.001* |
| SEA + CBZ | 1.6 (1.4) | 1.2 (1.2) | 1.1 (1.0) | 1.1 (1.0) | 0.9 (1.1) | ||||||
| EA + P | 2.2 (1.2) | 1.3 (1.0) | 0.6 (0.7) | 0.4 (0.6) | 0.3 (0.5) | ||||||
| SEA + P | 1.6 (1.2) | 1.7 (1.1) | 1.7 (1.0) | 1.6 (1.0) | 1.7 (1.2) | ||||||
| The total number of pain attacksd | EA + CBZ | 199.8 (133.6) | 121.3 (98.5) | 52.8 (52.5) | 33.9 (43.6) | 48.2 (56.5) | 0.334 | 0.067 | 0.001* | 0.222 | < 0.001* |
| SEA + CBZ | 161.8 (79.5) | 108.1 (57.2) | 54.9 (38.8) | 33.1 (45.7) | 27.9 (31.9) | ||||||
| EA + P | 230.5 (210.0) | 147.8 (164.9) | 108.9 (107.5) | 78.8 (86.0) | 76.8 (87.0) | ||||||
| SEA + P | 225.0 (211.5) | 231.9 (286.0) | 198.3 (209.5) | 166.7 (211.0) | 168.9 (214.1) | ||||||
| BPI-Faciale | |||||||||||
| General interference items | EA + CBZ | 28.3 (14.6) | 12.0 (11.9) | 6.3 (10.0) | 4.8 (8.6) | 6.8 (10.5) | 0.184 | 0.058 | 0.001* | 0.046* | < 0.001* |
| SEA + CBZ | 27.3 (16.3) | 16.9 (14.8) | 14.6 (12.3) | 11.6 (10.7) | 11.0 (11.6) | ||||||
| EA + P | 25.9 (12.9) | 15.0 (9.7) | 8.6 (8.2) | 5.0 (7.6) | 4.6 (6.7) | ||||||
| SEA + P | 28.2 (16.7) | 23.2 (14.9) | 22.8 (14.7) | 21.3 (15.6) | 21.5 (16.2) | ||||||
| Facial interference items | EA + CBZ | 29.8 (16.9) | 13.7 (9.3) | 6.1 (8.3) | 8.4 (12.0) | 10.1 (13.0) | 0.008* | 0.136 | < 0.001* | 0.004* | < 0.001* |
| SEA + CBZ | 31.4 (16.9) | 19.1 (14.9) | 17.0 (15.2) | 14.7 (15.6) | 12.5 (14.2) | ||||||
| EA + P | 31.9 (14.9) | 22.5 (16.5) | 12.3 (10.2) | 8.0 (11.3) | 7.9 (10.7) | ||||||
| SEA + P | 33.9 (16.3) | 28.5 (14.5) | 26.4 (14.9) | 25.9 (15.5) | 25.8 (17.7) | ||||||
| SF-36 | EA + CBZ | 112.0 (17.5) | 119.3 (16.9) | 127.2 (14.3) | 127.1 (13.2) | 126.1 (14.0) | 0.001* | 0.309 | 0.002* | 0.022* | < 0.001* |
| SEA + CBZ | 111.8 (15.4) | 114.5 (14.1) | 116.8 (13.8) | 121.0 (15.2) | 122.9 (15.8) | ||||||
| EA + P | 102.5 (17.8) | 117.0 (16.8) | 123.5 (16.8) | 126.4 (17.4) | 127.4 (15.9) | ||||||
| SEA + P | 111.1 (14.9) | 108.6 (12.9) | 110.0 (12.7) | 110.5 (12.4) | 108.8 (11.8) | ||||||
| PGICf | EA + CBZ | 4.1 (0.4) | 6.0 (0.9) | 6.6 (0.6) | 6.3 (0.9) | 6.2 (0.9) | 0.059 | 0.023* | < 0.001* | < 0.001* | < 0.001* |
| SEA + CBZ | 4.0 (0.0) | 5.5 (0.7) | 5.4 (0.7) | 5.5 (0.8) | 5.4 (0.8) | ||||||
| EA + P | 4.0 (0.2) | 5.7 (0.9) | 6.3 (0.7) | 6.0 (0.9) | 6.4 (0.9) | ||||||
| SEA + P | 4.0 (0.2) | 4.6 (0.7) | 4.7 (1.0) | 4.7 (1.0) | 4.8 (0.9) | ||||||
aThe Mean (SD) was used to recorded the results of groups, and the change in each outcome was analyzed from baseline to week 28, including the P value for EA × CBZ × time 3-way interaction, and EA × CBZ interaction, and P value for main effect of EA, CBZ, and time respectively
bVAS score range is from 0 to 10, with higher scores indicating greater pain
cIncluding PRI and PPI. The PRI was comprised of sensory and affective scale, each selected word was scored from 0 (none) to 3 (severe). The total PRI score was obtained by summing the item scores. The PPI range from 0–5, with higher scores indicating greater pain
dThe total number of pain attacks was calculated by summing the number of pain attacks in the past two weeks prior to the every assessment time-point
eIncluding general interference items and facial interference items. The total score of general interference items was sum of the 7 questions that address pain interference with general activities of daily living (ADL), score range is from 0 to 70, with higher scores indicating greater impact. The total score of facial interference items was sum of the 7 questions that address pain interference with face-specific daily activities, score range is from 0 to 70, with higher scores indicating greater impact
fThe PGIC evaluated overall health status as perceived by the patient in a seven-point single-item scale ranging from ‘very much worse’ to ‘very much improved’. For descriptive purposes, patients were classified into three categories according to the PGIC score: disease deterioration (0–3 points), stable disease (4 points) or disease improvement (5–7 points) since the initial baseline visit
gMultiple comparisons between the groups were compared by using Sidak test
*P < 0.05
Abbreviations: VAS, visual analog scale; SF-MPQ, Short-Form McGill pain questionnaire; PRI, pain rating index; PPI, present pain intensity; BPI-Facial, brief pain inventory-facial scale; SF-36, Short-Form 36 questionnaire; PGIC, patient global impression of change; SD, standard difference. EA + CBZ, electroacupuncture plus carbarmazepine (at the dosage of 300 mg/day); SEA + CBZ, sham electroacupuncture plus carbarmazepine (at the dosage of 300 mg/day); EA + P, electroacupuncture plus placebo, SEA + P, sham electroacupuncture plus placebo